Bioprocess Validation Market

Bioprocess Validation Market Size

The global bioprocess validation market size was valued at around USD 416.5 million in 2023 and is estimated to grow at 10.7% CAGR from 2024 to 2032. Bioprocess validation is a methodical plan in the biopharmaceutical industry, which emphasizes that bioproducts are manufactured without quality compromises. It encompasses all the documented tests and analyses of the various stages of the bioprocess, starting with raw materials and concluding with final goods, which are finished products. Such monitoring techniques are used to ensure that safe and effective therapeutic products are manufactured.

The increasing need for outsourced production is a major driver of this market as it stimulates the outsourcing of the production of complex items. The surge in the demand for biopharmaceuticals that include monoclonal antibodies, vaccines, and gene therapies is a significant driver. There are also extensive validation and compliance requirements set around these products emphasizing the quality, safety, and efficacy validation which fuels the need for validation services. The World Health Organization (WHO) estimates more than 320 active vaccine candidates for COVID-19 in 2021 alone, reflecting the boom in biopharmaceutical development activity which would require stringent validation.

Further, for the appropriate use of biopharmaceutical products, comprehensive validation ensures safety and quality claims. The same also applies to the elaborate balance of cGMPs and other regulations that require processes for detailed validation and monitoring. In the year 2020, the FDA's Center for Biologics Evaluation and Research (CBER) had given therapeutic drugs approval for 56, and it strengthens the idea that robust validation needs to be practiced further in the biopharmaceutical field.

Bioprocess Validation Market Trends

• The enhanced reliance on Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) by biopharmaceutical enterprises for improved production management and budgetary considerations is increasing the demand for third-party bioprocess validation services.
  

• Increased contracting permits businesses to focus on core competencies without increasing internal resources. NIH indicates an increasing number of biopharmaceutical companies using CMO/CDMOs, which translates into higher demand for skilled external validation.
  

• Moreover, single-use systems, continuous biomanufacturing, and automation are few examples of new bioprocessing technologies that will demand new types of validation strategies. Increased and varied bioprocessing techniques pose challenges to validation that need to be solved to improve product quality and manufacturing productivity.
  

• Also, transforming global health silos into a collective effort, the FDA published a new guide in 2021 on remote data gathering through digital tools in clinical research, emphasizing the need for validation of these tools in bioprocessing. The processes for validation and verification of these bioprocessing technologies will, however, become more critical as biopharmaceuticals get produced for a broader patient population.
  

Bioprocess Validation Market Analysis

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The market is segmented by testing type, including extractables/leachables testing, microbiological testing, integrity testing, viral clearance testing, adventitious agent testing, mycoplasma testing, physiochemical testing, compatibility testing, and other testing types. In 2023, the microbiological testing segment led the market, generating a revenue of USD 126.2 million.

• With the rapid development of biopharmaceuticals, agencies such as the FDA, EMA, and WHO have raised the standards for microbiological testing leading to more stringent processes. The FDA in its Guidance for Industry on Sterile Drug Products Produced by aseptic processing encourages proper monitoring.
  
• Also, the Good Manufacturing Practices (GMP) rules specify that microbiological testing must be performed at different levels of bioproduction to ensure safety and efficacy. These continuing processes illustrate the primary scenario and need for effective microbiological testing for patient health, safety and product quality.
  
• Moreover, the acceleration in the development of biologics, biosimilars, and gene therapies has led to greater importance for thorough microbiological testing. There have been higher rates of biosimilar approvals by the FDA from 2016-2021, over 30, which only increases the emphasis that needs to be placed on strict standards of testing.
  
• Smaller batch size production of most personalized medicines necessitates more stringent contamination controls to enhance cross-contamination prevention. This shift towards personalized therapies further necessitates enhanced microbiological testing to maintain product quality.
  
• The development of new microbiological testing approaches such as Rapid Microbiological Methods (RMM), polymerase chain reaction (PCR) based methods, and automation have enhanced the speed, detection, and efficiency of contamination checking. These procedures greatly assist in lowering the time needed for quality validation, leading to faster patient delivery for biopharmaceuticals.
  
• Thus, these factors seem likely to maintain the need for these standard formulas within the foreseeable future.

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Based on stage, the bioprocess validation market is segmented into process design, process qualification, and continued process verification. In 2023, the process qualification segment led the market, capturing a dominant revenue share of 46.8%.

• Qualification of processes (PQ) is an essential step for bioprocess validation. The objective of a PQ is to demonstrate that the biomanufacturing process achieves bioproduct quality consistently. Typically, qualification of processes follows after the process design and comes before the continued process verification during the validation lifecycle. It involves the examination of processes under conditions that are prone to realistic operational scenarios to confirm robustness and reproducibility processes.
  
• Therefore, there is an increasing qualification service need for validation of these systems for scale, sterility, and contamination control.
  
• Thus, owing to these aspects, the process qualification is expected to grow significantly within the next few years.
  

The bioprocess validation market is bifurcated into in-house and outsourced based on mode. The in-house segment is projected to reach USD 702 million by 2032.

• In-house bioprocess validation refers to the situation when validation of processes of biotechnology biopharmaceutical companies is done at their facilities instead of outsourcing. This strategy increases the ability to manage product quality, compliance with regulations, and protection of trade secrets.
  
• Several businesses prefer in-house validation because of the sensitive nature of the work processes undertaken and to ensure compliance with stringent controls, particularly for complicated biologics.
  
• Moreover, the growing number of biopharmaceutical companies adopting continuous manufacturing and Quality by Design (QbD) concepts is creating a deep need for continuous, internal validation and process control. This makes it possible to enhance processes continuously, reduce variation, and control quality.
  
• Thus, considering these factors, the internal segment is poised for solid development in the coming years.
  

The bioprocess validation market is segmented by application into biopharmaceuticals, gene and cell therapy, vaccines, and other applications. In 2023, the biopharmaceuticals segment was valued at USD 215.9 million.

• The entire value chain of biopharmaceutical manufacturing bears added complexities as there is increased sensitivity in the processes compared to traditional pharmaceutical manufacturing. Differences in raw material, cell cultures, and even the surrounding environment can drastically alter the final product quality.
  
• Thus, along with the need to monitor the vanquishing product quality from batch to batch, bioprocess validation is needed. These realities taken together with the fact that there is quite an increasing need for biologics underlines the increasing importance of bioprocess validation in biopharmaceutical manufacturing, especially regarding product quality, safety, and efficacy.
  
• Moreover, increasing incidence of chronic conditions and complex diseases has led to increased demand for biologics such as monoclonal antibodies, vaccines, and gene therapies.
  

The bioprocess validation market is segmented by end use into pharmaceutical companies, biotechnology companies, CROs and CDMOs, and academic and research institutes. In 2023, the pharmaceutical companies’ segment was valued at USD 187.9 million.

• The pharmaceutical industry is rapidly improving in biologics, cell, gene therapies, and new therapies such as biosimilars. These new technologies are more complex than the traditional systems and therefore more prone to errors during the manufacturing processes.
  
• Moreover, there are more than 400 cell and gene therapy products in various stages of development as of 2020, according to the data collected by the U.S. FDA. Considering this, it is imperative that robust bioprocess validation is carried out to ensure consistency and control variability. Such trends underline the importance of bioprocess validation in pharmaceutical companies.

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In 2023, the U.S. bioprocess validation market was valued at USD 174.5 million, with projections indicating a growth rate of 10.8% CAGR over the forecast period.

• The regulatory authorities such as FDA in U.S. put in place strict measures concerning biopharmaceutical production. These rules require all bioprocesses to be validated in detail to meet safety, efficacy, and quality requirements. It is mandatory across the board on verification requirements that enterprises comply with Good Manufacturing Practice (GMP) regulations. Such regulatory doses necessitate spending on novel processes in the broad framework of validation.
  
• Further, demand is sufficiently met by the well-developed healthcare infrastructure and spending on new therapies. Careful bioprocess validation for each of these products is necessary due to the complex nature of these items.
  
• In addition, the scaling up of U.S. personalized medicine increases the demand for specific bioprocesses and therefore, more attention to detail is required for validation. Thus, owing to such aforementioned factors, the activity in the U.S. market is expected to grow in the following years.
  

From 2024 to 2032, the UK bioprocess validation market is set for notable expansion.

• The UK is notable for its biotechnology and biopharmaceutical specialty, hosting many companies engaged in the development of biologics, cell and gene therapies, and advanced therapeutic medicinal products (ATMPs). This wide-ranging portfolio necessitates comprehensive bioprocess validation, especially for new therapies that are moving into clinical or commercial stages.
  
• The validation activities will be intensified, as companies need to serve both the domestic market as well as the export market. These operations need to be carried out in the new facilities to meet the demands of the growing industry and therefore validation becomes important.
  
• With people becoming more informed and the government more supportive, growth of the region's market is expected to increase dramatically in the coming years.
  

Saudi Arabia bioprocess validation market is poised for significant growth from 2024 to 2032.

• By the year 2030, the nation of Saudi Arabia has plans in place to invest heavily in biopharmaceutical research, development, and manufacturing. The government initiative to endorse the self-sufficiency of the nation's pharmaceutical manufacturing industry will reduce reliance on imported goods. This strategy not only aids in the growth of domestic manufacturing plants but also leads to increased investment towards bioprocess validation and biopharmaceuticals such as drug substances.
  
• Thus, the combined effects of these strategies will lead to faster growth rates in the region in the future and thus marketing opportunities emerging in these biopharmaceuticals.
  

Bioprocess Validation Market Share

The competition in the market for bioprocess validation is becoming more intense due to the presence of large and medium-sized companies and new firms entering the market. A significant method of maintaining one step ahead in this field is to develop new products powered by various technologies, and this is utilized by the majority of the most influential players. They are in a strong position because they are well financed and heavily researched. Moreover, it is important and advantageous to be at the forefront of adjusting to changes in regulations through making strategic partnerships, buyouts, and mergers to capture market share and expand internationally.

Bioprocess Validation Market Companies

Some of the eminent market participants operating in the bioprocess validation industry include:

• Asahi Kasei Corporation
• Bio-Rad Laboratories
• Charles River Laboratories
• Danaher Corporation
• Eurofins Scientific
• Lonza Group
• Meissner Filtration Products
• Merck KGaA
• Pace Analytical Services
• Repligen Corporation
• Sartorius AG
• SGS S.A.
• Thermo Fisher Scientific
• Tosoh Corporation
• WuXi AppTec
  

USPs for Top Players:

• Lonza Group offers full-service validation solutions for regulatory compliance and product safety in bioprocessing.
  
• Sartorius AG is focused on providing effective and validated systems for biopharmaceutical production.
  
• Thermo Fisher Scientific is able to tender full-service validation with emphasis on precision and compliance for bioprocessing workflows.
  

Bioprocess Validation Market Industry News:

• In July 2024, BioProcess360 Partners announced the launch of an investment fund aimed at supporting businesses involved in the development of emerging tools and technologies for the bioprocessing of traditional monoclonal antibodies (mAbs) and newer drug modalities. The fund is designed to assist companies in overcoming challenges related to research and development (R&D) and commercialization by providing investment capital, expert industry support, and connections to leading global biopharmaceutical companies.
  
• In October 2024, Thermo Fisher Scientific signed a Memorandum of Understanding (MoU) with the Government of Telangana to establish a bioprocess design center (BDC) in Genome Valley, Hyderabad. Covering a total area of 10,000 square feet, the bioprocess design center is set to become operational in early 2025. It is intended to serve as a benchmark for accelerating the development and manufacturing of innovative biotherapeutics in India and the Asia-Pacific region. The center will feature state-of-the-art laboratories and training hubs to promote scientific research.
  

The bioprocess validation market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Testing Type

• Extractables/leachables testing
• Microbiological testing
• Integrity testing
• Viral clearance testing
• Adventitious agent testing
• Mycoplasma testing
• Physiochemical testing
• Compatibility testing
• Other testing types

Market, By Stage

• Process design
• Process qualification
• Continued process verification

Market, By Mode

• In-house
• Outsourced

Market, By Application

• Biopharmaceuticals
• Gene and cell therapy
• Vaccines
• Other applications

Market, By End Use          

• Pharmaceutical companies
• Biotechnology companies
• CROs and CDMOs
• Academic and research institutes

The above information is provided for the following regions and countries:

• North America 
  • U.S.
  • Canada 
• Europe 
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands 
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea 
• Latin America 
  • Brazil
  • Mexico
  • Argentina 
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE